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NCT Number: NCT07416760

Analysis of the Composition of the Intestinal Microbiota in Patients Post-intestinal Anastomosis

Recent research suggests a significant link between gut microbiota and anastomotic leakage (AL) in colorectal surgery. Patients who develop AL have a higher abundance of bacteria from the Lachnospiraceae family and lower microbial diversity.

Considering the bibliographic data, our main interest is to analyze the microbial population of patients in our social environment and then look for differences in the microbiome between those who have suffered an anastomotic dehiscence (around 8-9% according to the results of our hospital's Surgery Department) and those who have not.

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Key information

Conditions

Abdominal Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The study is designed as a prospective, descriptive, non-interventional research project in which some variables will be analyzed transversally. Patients will be selected by the clinical members of the research team from within the population in our setting who will undergo abdominal surgery involving colorectal intestinal anastomosis. Once accepted, stool samples will be requested prior to surgical preparation, during surgery, and afterwards to determine their microbiome; in this way, we will attempt to correlate the evolution of their anastomosis with their intestinal bacterial population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have undergone colorectal intestinal anastomosis.
  • Signing of the informed consent form.
  • Age ≥18 years with good functional status.
  • Availability for postoperative follow-up.

Exclusion criteria

  • Emergency surgery.
  • Intra-abdominal sepsis or previous dehiscence.
  • Severe immunosuppression.
  • Use of antibiotics in the 3 months prior to preoperative preparation.
  • Pregnancy or breastfeeding.

Treatment and study plan

Not applicable- observational study

Other

Fecal sample collection

Primary outcomes

  1. Understand the patient's microbiome

    Time frame: From enrollment to a month post surgery

    To understand the microbiome of patients undergoing colorectal surgery and the effect of current surgical preparation on the microbiota in our local population.

Secondary outcomes

  1. Predictive indicators of colorectal anastomosis postsurgery

    Time frame: From surgery to a month

    Predictive indicators of postoperative outcomes in patients undergoing colorectal anastomosis surgery through metagenomic characterization of the gut microbiota.

Study contacts

Contact information is provided by the study sponsor or research team.

Héctor Guadalajara-Labajo, MD, PhD

CONTACT

[email protected]

+ 34 550 4800 ext. 4331

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Registry information

Official study title

Analysis of the Composition of the Intestinal Microbiota and Its Evolution in Patients Post-intestinal Anastomosis

Acronym: MIDESIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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